Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)

Not Applicable

Recruiting

• Conditions: High Blood Pressure
• Interventions: Behavioral: Control Condition; Behavioral: Regret Lottery

• Registration Number: NCT04114669
• Lead Sponsor: NYU Langone Health

Brief Summary

BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) is a phase II, single-center, prospective, pragmatic randomized clinical trial within the New York City Health and Hospitals (NYC-H+H) system and NYU Langone Family Health Centers. The trial will recruit from 3 NYC-H+H ambulatory clinics as well as NYU Langone Family Health Centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. The trial will randomize 435 patients with hypertension determined to have poor adherence (\<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. Baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Study Start: 2020-07-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-03-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

• A diagnosis of hypertension.

• An active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ACE inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator).

  • 1 ambulatory systolic blood pressure ≥140 mmHg (on therapy).

• Suboptimal adherence (self-report).

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Exclusion Criteria

• Incarcerated
• Pregnant
• Unable to use study software (Way To Health) in English or Spanish
• Unable/unwilling to consent
• Clear barrier to technology use (e.g. visual or hearing impairment)
• Projected life expectancy <12 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Condition	Control Condition	Will complete a total of 3 in-person study visits, approximately one hour each.
Regret lottery	Regret Lottery	Will receive a lottery incentive ("regret lottery") for 6 months

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP)	baseline to 12 Months	Three seated BPs will be measured after a rest period (5 minutes) using an automated device (Omron, Lake Forest, IL) which will reduce the potential for observer bias.
Adherence	12 Months	Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States